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Pg1}{\bkmkend Pg1}\par\pard\ql \li1308\sb0\sl-322\slmult0 \par\pard\ql\li1308\sb0\sl-322\slmult0 \par\pard\ql\li1308\sb0\sl-322\slmult0 \par\pard\ql\li1308\sb0\sl-322\slmult0 \par\pard\ql\li1308\sb0\sl-322\slmult0 \par\pard\ql\li1308\sb0\sl-322\slmult0 \par\pard\ql\li1308\sb302\sl-322\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf2\f3\fs28 Patient Protection and Affordable Care Act (H.R. 3590)\u8212?Approval Pathway for \par\pard\ql \li4298\sb0\sl-320\slmult0 \up0 \expndtw-4\charscalex100 Biosimilar Biological Products \par\pard\ql \li1080\ri182\sb246\sl-265\slmult0 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf3\f4\fs22 On December 24, 2009, the U.S. Senate passed the Patient Protection and Affordable Care Act (H.R. 3590), its version of \up0 \expndtw-2\charscalex100 comprehensive healthcare reform legislation. On March 21, 2010, the U.S. House of Representatives also passed this \line \up0 \expndtw-2\charscalex100 legislation; and it\ul0\nosupersub\cf4\f5\fs24 was signed into law by the President on March 23, 2010\ul0\nosupersub\cf3\f4\fs22 . Included therein is a provision (Section \up0 \expndtw-2\charscalex100 7002) amending the Public Health Service Act to permit approval of biosimilar biological products through an abbreviated \up0 \expndtw-2\charscalex100 biological license application (ABLA) submitted to the Food and Drug Administration (FDA). \par\pard\ql \li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb152\sl-253\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf5\f6\fs22 Patient Protection and Affordable Care Act \par\pard\ql \li6386\sb1\sl-237\slmult0 \up0 \expndtw-3\charscalex100 (H.R. 3590) \par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb110\sl-230\slmult0\fi0\tx2815 \dn2 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Approval\tab \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf7\f8\fs20 Amends section 351 of the Public Health Service Act (PHSA) to create an abbreviated biological\par\pard\li1080\sb0\sl-230\slmult0\fi0\tx2815 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Pathway\tab \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf7\f8\fs20 product application (aBPA) for\ul0\nosupersub\cf6\f7\fs20 \u8220?highly similar\u8221?\ul0\nosupersub\cf7\f8\fs20 biological products.\par\pard\ql \li2815\sb219\sl-230\slmult0 \up0 \expndtw-3\charscalex100 Permits an FOB to be evaluated against only\ul0\nosupersub\cf6\f7\fs20 one reference listed product. \par\pard\ql \li3031\sb1\sl-217\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 Note: this allows only a single biological product to serve as a reference biological product. \par\pard\ql \li2815\sb0\sl-230\slmult0 \par\pard\ql\li2815\sb3\sl-230\slmult0 \up0 \expndtw-3\charscalex100 A \u8220?biosimilar\u8221? product is a product that is \u8220?\ul0\nosupersub\cf6\f7\fs20 highly similar\u8221?\ul0\nosupersub\cf7\f8\fs20 to the reference product \par\pard\qj \li2815\ri1206\sb10\sl-230\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf6\f7\fs20 \u8220?notwithstanding minor differences in clinically inactive components,\u8221?\ul0\nosupersub\cf7\f8\fs20 and for which there are \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf6\f7\fs20 \u8220?no clinically meaningful differences between the biological product and the reference product \up0 \expndtw-4\charscalex100 in terms of safety, purity and potency of the product.\u8221? \par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb50\sl-230\slmult0\fi0\tx2815 \dn2 \expndtw-2\charscalex100 Clinical\tab \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf7\f8\fs20 Permits the Secretary, at his\ul0\nosupersub\cf6\f7\fs20 discretion,\ul0\nosupersub\cf7\f8\fs20 to issue\ul0\nosupersub\cf6\f7\fs20 guidance documents,\ul0\nosupersub\cf7\f8\fs20 with opportunity for public\par\pard\li1080\sb0\sl-230\slmult0\fi0\tx2815 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Standards\tab \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf7\f8\fs20 comment, on the process for submission of an aBPA. Guidance documents may be general or product\par\pard\ql \li2815\sb1\sl-205\slmult0 \up0 \expndtw-3\charscalex100 specific. The Secretary must provide a process through which the public can provide input on \par\pard\qj \li2815\ri1108\sb15\sl-230\slmult0 \up0 \expndtw-3\charscalex100 priorities for issuing guidance. Issuance of guidance is not a prerequisite for approval of an FOB, and \up0 \expndtw-3\charscalex100 the Secretary may determine that the science does not allow for safe approval of an FOB for a certain \up0 \expndtw-4\charscalex100 product or product class in a guidance document. \par\pard\ql \li2815\sb230\sl-230\slmult0 \up0 \expndtw-3\charscalex100 The Secretary must license an aBPA if the Secretary determines the information submitted is \par\pard\ql \li2815\sb1\sl-217\slmult0 \up0 \expndtw-3\charscalex100 sufficient to show the FOB is\ul0\nosupersub\cf6\f7\fs20 \u8220?biosimilar\u8221?\ul0\nosupersub\cf7\f8\fs20 to the innovator product or\ul0\nosupersub\cf6\f7\fs20 \u8220?interchangeable\u8221?\ul0\nosupersub\cf7\f8\fs20 with the \par\pard\qj \li2815\ri1066\sb21\sl-220\slmult0 \up0 \expndtw-3\charscalex100 innovator product and if the applicant consents to inspection of the manufacturing facility. To support \up0 \expndtw-4\charscalex100 approval of the aBPA, the FOB must show that the biological product: \par\pard\ql \li2988\ri1090\sb12\sl-230\slmult0\tx3232\tx3232\tx3232\tx3232 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf6\f7\fs20 is \u8220?biosimilar to the reference product,\u8221?\ul0\nosupersub\cf7\f8\fs20 based upon data from: (1) analytical studies to show \line\tab \up0 \expndtw-3\charscalex100 the FOB is\ul0\nosupersub\cf6\f7\fs20 \u8220?highly similar\u8221?\ul0\nosupersub\cf7\f8\fs20 to the reference product, \u8220?notwithstanding minor differences in \line \tab \up0 \expndtw-3\charscalex100 clinically inactive components\u8221?; (2) animal studies; and (3) a\ul0\nosupersub\cf6\f7\fs20 clinical study\ul0\nosupersub\cf7\f8\fs20 or studies (including \line \tab \up0 \expndtw-3\charscalex100 assessment of immunogenicity) to demonstrate \u8220?safety, purity, and potency\u8221? for one or more \line \tab \up0 \expndtw-3\charscalex100 appropriate conditions of use for which the innovator product is licensed. \par\pard\ql \li2983\ri1133\sb0\sl-240\slmult0\tx3223 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 utilizes the\ul0\nosupersub\cf6\f7\fs20 same mechanism(s) of action\ul0\nosupersub\cf7\f8\fs20 for the condition(s) of use listed in the labeling, to the \line\tab \up0 \expndtw-3\charscalex100 extent the mechanism of action is known for the innovator product; \par\pard\ql \li2983\ri1169\sb0\sl-240\slmult0\tx3223 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 has\ul0\nosupersub\cf6\f7\fs20 the same condition(s) of use\ul0\nosupersub\cf7\f8\fs20 listed in the labeling as have been previously approved for the \line\tab \up0 \expndtw-2\charscalex100 innovator product; \par\pard\ql \li2983\sb0\sl-180\slmult0 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 has the\ul0\nosupersub\cf6\f7\fs20 same route of administration, dosage form and strength\ul0\nosupersub\cf7\f8\fs20 as the innovator product; \par\pard\ql \li2983\ri1363\sb19\sl-220\slmult0\tx3223 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 the FOB\ul0\nosupersub\cf6\f7\fs20 manufacturing facility meets appropriate standards\ul0\nosupersub\cf7\f8\fs20 to ensure the product is safe, \line\tab \up0 \expndtw-2\charscalex100 pure and potent; and \par\pard\ql \li6376\sb0\sl-207\slmult0 \par\pard\ql\li6376\sb124\sl-207\slmult0 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf1\f2\fs18 -1-\par\pard\sect\sectd\fs24\paperw12240\paperh15840{\shp
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Pg2}{\bkmkend Pg2}\par\pard\ql \li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb106\sl-253\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf5\f6\fs22 Patient Protection and Affordable Care Act \par\pard\ql \li6386\sb7\sl-253\slmult0 \up0 \expndtw-3\charscalex100 (H.R. 3590) \par\pard\ql \li2983\sb0\sl-220\slmult0 \par\pard\ql\li2983\sb0\sl-220\slmult0 \par\pard\ql\li2983\ri2165\sb115\sl-220\slmult0\tx3223 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf6\f7\fs20 additional information at the option of the FOB\ul0\nosupersub\cf7\f8\fs20 applicant, including information \line\tab \up0 \expndtw-2\charscalex100 demonstrating that the FOB is interchangeable with the innovator product. \par\pard\qj \li2815\ri2244\sb224\sl-240\slmult0 \up0 \expndtw-3\charscalex100 The Secretary, at his discretion, may waive any of these requirements on a case-by-case \line \up0 \expndtw-4\charscalex100 basis. \par\pard\qj \li2815\sb0\sl-220\slmult0 \par\pard\qj\li2815\ri1598\sb17\sl-220\slmult0 \up0 \expndtw-3\charscalex100 The FOB may only be reviewed and approved for indications for which the reference product is \up0 \expndtw-4\charscalex100 already approved. \par\pard\ql \li2815\ri1085\sb231\sl-232\slmult0 \up0 \expndtw-3\charscalex100 Requires the Secretary to approve all biological products under section 351 of the PHS, unless: (1) the \line \up0 \expndtw-3\charscalex100 biological product is in a product class for which a biological product in such product class is the \line \up0 \expndtw-3\charscalex100 subject of an application approved under section 505 of the FFDCA not later than the date of \line \up0 \expndtw-3\charscalex100 enactment of this Act; and (2) the FOB application has been submitted to the FDA before the date of \line \up0 \expndtw-3\charscalex100 enactment of this Act or not later than 10 years after the date of enactment of this Act; and (3) there is \line \up0 \expndtw-3\charscalex100 no section 351 licensed biological product which could serve as a reference product. \par\pard\ql \li2815\sb230\sl-230\slmult0 \up0 \expndtw-3\charscalex100 Requires FDA review of the FOB application by the division that reviewed the reference product. \par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb76\sl-230\slmult0\fi0\tx2815 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Safety and\tab \up0 \expndtw-1\charscalex100 Requires clinical studies\ul0\nosupersub\cf7\f8\fs20 to assess immunogenicity, pharmacokinetics and pharmacodynamics, but\par\pard\li1080\sb0\sl-230\slmult0\fi0\tx2815 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Immunogenicity\tab \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf7\f8\fs20 such studies\ul0\nosupersub\cf6\f7\fs20 may be waived\ul0\nosupersub\cf7\f8\fs20 by the Secretary at his discretion.\par\pard\li2815\sb226\sl-230\slmult0\fi0 \up0 \expndtw-1\charscalex100 Applies the\ul0\nosupersub\cf6\f7\fs20 REMS requirement\ul0\nosupersub\cf7\f8\fs20 to FOBs in the same manner it is applied to innovator biologics\par\pard\li2815\sb1\sl-230\slmult0\fi0 \up0 \expndtw-2\charscalex100 licensed under the PHS.\par\pard\li1080\sb0\sl-218\slmult0\par\pard\li1080\sb0\sl-218\slmult0\par\pard\li1080\sb0\sl-218\slmult0\par\pard\li1080\sb12\sl-218\slmult0\fi0\tx2815 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf9\f10\fs18 Interchangeability\tab \dn3 \expndtw-1\charscalex100 \ul0\nosupersub\cf7\f8\fs20 If the conditions for interchangeability are met, requires the Secretary to determine the FOB to be\par\pard\li1080\sb0\sl-213\slmult0\fi0\tx2815 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 and Substitution\tab \dn2 \expndtw-1\charscalex100 \ul0\nosupersub\cf7\f8\fs20 interchangeable with the reference product at the time of approval. Defines an\ul0\nosupersub\cf6\f7\fs20 interchangeable\ul0\nosupersub\cf7\f8\fs20 FOB\par\pard\ql \li2815\sb11\sl-230\slmult0 \up0 \expndtw-4\charscalex100 as a product that is: \par\pard\ql \li2983\sb10\sl-230\slmult0\tx3223 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929? \tab \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 \u8220?biosimilar\ul0\nosupersub\cf7\f8\fs20 \u8221? to the reference product; \par\pard\ql \li2983\ri1244\sb0\sl-240\slmult0\tx3223 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 can be\ul0\nosupersub\cf6\f7\fs20 \u8220?expected to produce the same clinical result\u8221?\ul0\nosupersub\cf7\f8\fs20 as the reference product in\ul0\nosupersub\cf6\f7\fs20 \u8220?any given \line\tab \up0 \expndtw-3\charscalex100 patient\u8221?\ul0\nosupersub\cf7\f8\fs20 ; and \par\pard\ql \li2983\sb1\sl-193\slmult0 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 the\ul0\nosupersub\cf6\f7\fs20 risk of safety or diminished efficacy\ul0\nosupersub\cf7\f8\fs20 of alternating or switching between the FOB and \par\pard\qj \li3223\ri1123\sb25\sl-220\slmult0 \up0 \expndtw-3\charscalex100 innovator product is\ul0\nosupersub\cf6\f7\fs20 not greater than the risk of using the innovator product with no switch\ul0\nosupersub\cf7\f8\fs20 , \up0 \expndtw-4\charscalex100 if the biologic is intended for use by more than one patient. \par\pard\ql \li2815\sb0\sl-230\slmult0 \par\pard\ql\li2815\sb2\sl-230\slmult0 \up0 \expndtw-3\charscalex100 No guidance provision specific to interchangeability, but see above guidance requirements. \par\pard\qj \li2815\ri1868\sb222\sl-240\slmult0 \up0 \expndtw-3\charscalex100 If a product is \u8220?interchangeable\u8221? it may be substituted for the reference product \u8220?without the \up0 \expndtw-3\charscalex100 intervention of the health care provider who prescribed the reference product.\u8221? \par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb73\sl-230\slmult0\fi0\tx2815 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Naming\tab \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf7\f8\fs20 No naming provisions.\par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb68\sl-230\slmult0\fi0\tx2815 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Postmarket\tab \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf7\f8\fs20 Applies the\ul0\nosupersub\cf6\f7\fs20 REMS requirement\ul0\nosupersub\cf7\f8\fs20 to FOBs in the same manner it is applied to innovator biologics\par\pard\li1080\sb0\sl-228\slmult0\fi0\tx2815 \dn2 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Requirements\tab \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf7\f8\fs20 licensed under the PHS.\par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb69\sl-230\slmult0\fi0\tx2815 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Other\tab \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf7\f8\fs20 Provides for a\ul0\nosupersub\cf6\f7\fs20 public process\ul0\nosupersub\cf7\f8\fs20 with all stakeholders, including industry, scientific and academic\par\pard\sect\sectd\fs24\paperw12240\paperh15840{\shp
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Pg3}{\bkmkend Pg3}\par\pard\ql \li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb106\sl-253\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf5\f6\fs22 Patient Protection and Affordable Care Act \par\pard\ql \li6386\sb7\sl-253\slmult0 \up0 \expndtw-3\charscalex100 (H.R. 3590) \par\pard\ql \li2815\sb0\sl-230\slmult0 \par\pard\ql\li2815\sb0\sl-230\slmult0 \par\pard\ql\li2815\ri1173\sb86\sl-230\slmult0 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf7\f8\fs20 experts, Congress, patient representatives and healthcare professionals,\ul0\nosupersub\cf6\f7\fs20 to develop appropriate user \up0 \expndtw-1\charscalex100 fee\ul0\nosupersub\cf7\f8\fs20 s and FDA performance and safety goals for FOBs, to be implemented October 1, 2012. The \up0 \expndtw-2\charscalex100 public process must be started no later than October 1, 2010. \par\pard\qj \li2815\ri1112\sb0\sl-240\slmult0 \up0 \expndtw-1\charscalex100 Provides for data collection on the cost of reviewing aBPA applications from the date of enactment of \up0 \expndtw-2\charscalex100 this Act through October 1, 2010. \par\pard\ql \li2815\sb211\sl-230\slmult0 \up0 \expndtw-1\charscalex100 Requires a biennial audit, beginning two years after the first aBPA user fees is collected and ending \par\pard\qj \li2815\ri1040\sb0\sl-240\slmult0 \up0 \expndtw-1\charscalex100 October 1, 2013, comparing user fees collected with actual cost of reviewing the aBPA. Directs aBPA \up0 \expndtw-2\charscalex100 user fees to be adjusted accordingly after review of the audit. \par\pard\qj \li2815\ri1104\sb219\sl-220\slmult0 \up0 \expndtw-1\charscalex100 Deems a biological product with an approved section 505 application to be a license for the biological \up0 \expndtw-1\charscalex100 product under section 351 of the PHS 10 years after enactment of this Act \par\pard\ql \li2815\sb0\sl-230\slmult0 \par\pard\ql\li2815\sb2\sl-230\slmult0 \up0 \expndtw-3\charscalex100 Establishes within the Treasury the \u8220?Biologic Product Savings Fund\u8221? to be used for \u8220?activities \par\pard\qj \li2815\ri1100\sb10\sl-230\slmult0 \up0 \expndtw-3\charscalex100 authorized under the Public Health Service Act.\u8221? The BPSF is funded by annual appropriations in the \up0 \expndtw-3\charscalex100 amount equal to the amount that is saved by the Federal government as a result of this Act. Funds are \up0 \expndtw-4\charscalex100 available without fiscal year limitation. \par\pard\ql \li2815\sb230\sl-230\slmult0 \up0 \expndtw-3\charscalex100 Requires a GAO study and report to Congress not later than 3 years after enactment of BPCIA \par\pard\qj \li2815\ri1395\sb0\sl-240\slmult0 \up0 \expndtw-3\charscalex100 regarding the extent to which pediatric studies for biological products are being required under the \up0 \expndtw-4\charscalex100 FFDCA and any pediatric needs that are unmet under existing authority. \par\pard\ql \li2815\sb211\sl-230\slmult0 \up0 \expndtw-3\charscalex100 Clarifies that if a reference product has orphan drug status, an FOB application for a biosimilar \par\pard\qj \li2815\ri1119\sb0\sl-240\slmult0 \up0 \expndtw-3\charscalex100 product for the same indication may not be approved for the later of 12 years exclusivity period under \up0 \expndtw-4\charscalex100 BPCIA or the 7 year exclusivity period granted for orphan drugs. \par\pard\sect\sectd\fs24\paperw12240\paperh15840{\shp
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Pg4}{\bkmkend Pg4}\par\pard\ql \li1080\sb0\sl-230\slmult0 \par\pard\ql\li1080\sb0\sl-230\slmult0 \par\pard\ql\li1080\sb0\sl-230\slmult0 \par\pard\ql\li1080\sb0\sl-230\slmult0 \par\pard\ql\li1080\sb0\sl-230\slmult0 \par\pard\ql\li1080\sb60\sl-230\slmult0 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Exclusivity Provisions \par\pard\ql \li4675\sb0\sl-253\slmult0 \par\pard\ql\li4675\sb0\sl-253\slmult0 \par\pard\ql\li4675\sb5\sl-253\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf5\f6\fs22 Patient Protection and Affordable Care Act \par\pard\ql \li6136\sb5\sl-256\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf10\f11\fs24 (H.R. 3590) \par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb162\sl-230\slmult0\fi0\tx2755 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Innovator\tab \up0 \expndtw-2\charscalex100 42 U.S.C. § 262(l) (Public Health Service Act § 351(l))\par\pard\ql \li1080\sb1\sl-210\slmult0 \up0 \expndtw-4\charscalex100 Market and \par\pard\ql \li1080\sb14\sl-230\slmult0\tx2755 \up0 \expndtw-4\charscalex100 Data Exclusivity \tab \up0 \expndtw-4\charscalex100 \ul0\nosupersub\cf7\f8\fs20 Includes provisions for innovator product data and market exclusivity. \par\pard\ql \li2743\ri1485\sb0\sl-240\slmult0\tx3115 \up0 \expndtw0\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 The FOB applicant may not submit an application for approval for\ul0\nosupersub\cf6\f7\fs20 4 years\ul0\nosupersub\cf7\f8\fs20 after the reference \line\tab \up0 \expndtw-2\charscalex100 product was first approved. \par\pard\ql \li2884\ri1663\sb0\sl-240\slmult0\tx3115 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 FDA may not approve an FOB application until\ul0\nosupersub\cf6\f7\fs20 12 years\ul0\nosupersub\cf7\f8\fs20 after the reference product is first \line\tab \up0 \expndtw-2\charscalex100 licensed. \par\pard\ql \li2755\sb171\sl-230\slmult0 \up0 \expndtw-1\charscalex100 No new exclusivity is granted for BLA supplements or subsequent applications for a new \par\pard\ql \li2755\sb10\sl-230\slmult0 \up0 \expndtw-1\charscalex100 indication, route of administration, dosage form, or strength of a previously licensed biologic. \par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb83\sl-230\slmult0\fi0\tx2755 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 FOB Market\tab \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf7\f8\fs20 Provides\ul0\nosupersub\cf6\f7\fs20 one year\ul0\nosupersub\cf7\f8\fs20 of exclusivity for the first approved interchangeable FOB for a reference\par\pard\li1080\sb0\sl-230\slmult0\fi0\tx2755 \dn2 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Exclusivity\tab \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf7\f8\fs20 product. If an FOB is approved as interchangeable, the Secretary may approve other FOBs relying\par\pard\qj \li2755\ri1589\sb0\sl-230\slmult0 \up0 \expndtw-3\charscalex100 on the same reference product, but may not determine that such an FOB is interchangeable with \line \up0 \expndtw-3\charscalex100 the reference product until the earlier of one year after the first commercial marketing of the first \line \up0 \expndtw-3\charscalex100 interchangeable FOB or 18 or 42 two months depending on patent certification and litigation. \par\pard\sect\sectd\fs24\paperw12240\paperh15840{\shp
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Pg5}{\bkmkend Pg5}\par\pard\ql \li1080\sb0\sl-230\slmult0 \par\pard\ql\li1080\sb0\sl-230\slmult0 \par\pard\ql\li1080\sb0\sl-230\slmult0 \par\pard\ql\li1080\sb0\sl-230\slmult0 \par\pard\ql\li1080\sb0\sl-230\slmult0 \par\pard\ql\li1080\sb60\sl-230\slmult0 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Intellectual Property Provisions \par\pard\ql \li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb118\sl-253\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf5\f6\fs22 Patient Protection and Affordable Care Act \par\pard\ql \li6386\sb7\sl-253\slmult0 \up0 \expndtw-3\charscalex100 (H.R. 3590) \par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb77\sl-230\slmult0\fi0\tx2815 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Notification &\tab \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf11\f12\fs20 Confidential Access to aBPA for Patent Identification and Litigation Purposes.\par\pard\li1080\sb0\sl-230\slmult0\fi0 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Actions for\par\pard\li1080\sb1\sl-230\slmult0\fi0\tx2815 \up0 \expndtw-2\charscalex100 Infringement\tab \up0 \expndtw-1\charscalex100 PHS § 351 (l)(1), (2).\ul0\nosupersub\cf7\f8\fs20 Requires the FOB applicant to within 20 days of FDA notice that the aBPA\par\pard\ql \li2815\ri1064\sb0\sl-233\slmult0 \up0 \expndtw-3\charscalex100 was accepted for filing, to provide the reference product sponsor \u8220?confidential access\u8221? to a copy of the \up0 \expndtw-3\charscalex100 aBPA and other information that describes the manufacturing process. The FOB applicant may \line \up0 \expndtw-3\charscalex100 provide other information requested by the reference product sponsor. Such \u8220?confidential \line \up0 \expndtw-4\charscalex100 information\u8221? must be supplied to: \par\pard\ql \li2959\sb206\sl-230\slmult0 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 Outside counsel, defined as attorneys designated by the reference product sponsor, but not \par\pard\qj \li3146\ri1268\sb0\sl-240\slmult0 \up0 \expndtw-1\charscalex100 employed by the reference product sponsor and who do not engage in patent prosecution for the \up0 \expndtw-2\charscalex100 reference product. \par\pard\ql \li2959\ri1293\sb0\sl-240\slmult0 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 In-house counsel, defined as one attorney employed by the reference product sponsor who does \up0 \expndtw-2\charscalex100 not engage in patent prosecution for the reference product. \par\pard\ql \li2959\sb0\sl-180\slmult0 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 A representative of a third party owner of a patent exclusively licensed to a reference product \par\pard\qj \li3146\ri1239\sb11\sl-230\slmult0 \up0 \expndtw-3\charscalex100 sponsor, provided: 1) that the third party patent owner has retained a right to assert the patent or \line \up0 \expndtw-3\charscalex100 participate in litigation concerning the patent; and 2) that the representative informs the product \line \up0 \expndtw-3\charscalex100 sponsor and the FOB applicant of his/her agreement to be subject to confidentiality provisions. \par\pard\qj \li2815\sb0\sl-220\slmult0 \par\pard\qj\li2815\ri1481\sb19\sl-220\slmult0 \up0 \expndtw-3\charscalex100 Those privy to confidential information may not disclose the information to anyone without prior \up0 \expndtw-3\charscalex100 written consent of the FOB applicant, which may not be \u8220?unreasonably withheld.\u8221? \par\pard\qj \li2815\sb0\sl-230\slmult0 \par\pard\qj\li2815\ri1119\sb2\sl-230\slmult0 \up0 \expndtw-3\charscalex100 Confidential information may be used for the \u8220?sole and exclusive purpose\u8221? of determining whether a \up0 \expndtw-3\charscalex100 claim of patent infringement could be \u8220?reasonably asserted\u8221? with respect to each patent assigned to or \up0 \expndtw-4\charscalex100 exclusively licensed to the reference product sponsor. \par\pard\qj \li2815\ri1091\sb228\sl-233\slmult0 \up0 \expndtw-3\charscalex100 Ownership of the confidential information remains with the FOB applicant. If the reference product \up0 \expndtw-3\charscalex100 sponsor files a patent infringement suit, the use of confidential information is governed by this section \up0 \expndtw-3\charscalex100 (i.e., the information may not be shared or publicly revealed without prior written consent) until the \up0 \expndtw-4\charscalex100 court enters a protective order. \par\pard\qj \li2815\sb0\sl-226\slmult0 \par\pard\qj\li2815\ri1367\sb7\sl-226\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf11\f12\fs20 Rule of construction:\ul0\nosupersub\cf7\f8\fs20 Nothing in this subsection shall be construed \u8220?as an admission by the [FOB \up0 \expndtw-3\charscalex100 applicant] regarding the validity, enforceability, or infringement of any patent; or an agreement or \up0 \expndtw-3\charscalex100 admission by the [FOB applicant] with respect to the competency, relevance, or materiality of any \up0 \expndtw-4\charscalex100 confidential information.\u8221? \par\pard\ql \li2815\sb0\sl-230\slmult0 \par\pard\ql\li2815\sb1\sl-230\slmult0 \up0 \expndtw-3\charscalex100 Disclosure of any confidential information in violation of this section is considered to cause \par\pard\qj \li2815\ri1348\sb19\sl-220\slmult0 \up0 \expndtw-3\charscalex100 irreparable harm for which no legal remedy is sufficient (i.e, no monetary damages will adequately \up0 \expndtw-3\charscalex100 compensate the FOB applicant). Immediate injunctive relief is the appropriate remedy. \par\pard\ql \li2815\sb0\sl-230\slmult0 \par\pard\ql\li2815\sb0\sl-230\slmult0 \par\pard\ql\li2815\sb12\sl-230\slmult0 \up0 \expndtw-4\charscalex100 \ul0\nosupersub\cf11\f12\fs20 Procedure for Patent Identification \par\pard\qj \li2815\sb0\sl-220\slmult0 \par\pard\qj\li2815\ri1446\sb19\sl-220\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf6\f7\fs20 351(l)(3).\ul0\nosupersub\cf7\f8\fs20 Within 60 days of receiving the confidential information, the reference product sponsor \up0 \expndtw-4\charscalex100 must provide to the FOB applicant: \par\pard\ql \li3036\ri1195\sb20\sl-220\slmult0\tx3252 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 a list of patents for which the reference product sponsor believes a claim of patent infringement \line\tab \up0 \expndtw-4\charscalex100 could \u8220?reasonably be asserted\u8221? (by the sponsor or patent owner); and \par\pard\ql \li3036\ri1527\sb20\sl-220\slmult0\tx3252 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 an identification of the patents on the list the reference product sponsor would be willing to \line\tab \up0 \expndtw-2\charscalex100 license to the FOB applicant. \par\pard\sect\sectd\fs24\paperw12240\paperh15840{\shp
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Pg6}{\bkmkend Pg6}\par\pard\ql \li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb86\sl-253\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf5\f6\fs22 Patient Protection and Affordable Care Act \par\pard\ql \li6386\sb7\sl-253\slmult0 \up0 \expndtw-3\charscalex100 (H.R. 3590) \par\pard\qj \li2815\sb0\sl-230\slmult0 \par\pard\qj\li2815\sb0\sl-230\slmult0 \par\pard\qj\li2815\sb0\sl-230\slmult0 \par\pard\qj\li2815\ri1101\sb56\sl-230\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf7\f8\fs20 Within 60 days of receipt of the reference product sponsors list, the FOB applicant may provide to the \line \up0 \expndtw-3\charscalex100 reference product sponsor a list of patents to which the FOB applicant believes a patent infringement \line \up0 \expndtw-3\charscalex100 claim could be \u8220?reasonably asserted.\u8221? The FOB applicant must provide to reference product sponsor: \par\pard\ql \li2894\ri1045\sb230\sl-230\slmult0\tx3124\tx3124 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 A detailed \u8220?factual and legal\u8221? statement on a \u8220?claim by claim basis\u8221? as to why the patents listed by \line\tab \up0 \expndtw-3\charscalex100 the reference product sponsor and the patents listed in turn by the FOB applicant are invalid, \line \tab \up0 \expndtw-4\charscalex100 unenforceable or will not be infringed by the FOB product; \par\pard\ql \li2894\ri1311\sb19\sl-220\slmult0\tx3124 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 A statement that the FOB applicant will not begin commercial marketing of the FOB before the \line\tab \up0 \expndtw-2\charscalex100 patent expires; and \par\pard\ql \li2894\sb12\sl-230\slmult0 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 A response to the reference product sponsor\u8217?s offer to license specific patents. \par\pard\qj \li2815\sb0\sl-226\slmult0 \par\pard\qj\li2815\ri1415\sb8\sl-226\slmult0 \up0 \expndtw-3\charscalex100 Within 60 days after receipt of the FOB applicant\u8217?s response, the reference product sponsor must \up0 \expndtw-3\charscalex100 provide the FOB applicant a detailed \u8220?factual and legal\u8221? statement on a \u8220?claim by claim basis\u8221? for \up0 \expndtw-3\charscalex100 why the listed patents are infringed, and a response to the validity and enforceability statements \up0 \expndtw-4\charscalex100 provided by the FOB applicant. \par\pard\ql \li2815\sb0\sl-230\slmult0 \par\pard\ql\li2815\sb21\sl-230\slmult0 \up0 \expndtw-4\charscalex100 \ul0\nosupersub\cf11\f12\fs20 Good Faith Negotiations. \par\pard\ql \li2815\sb210\sl-230\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf6\f7\fs20 351(l)(4).\ul0\nosupersub\cf7\f8\fs20 Requires the FOB applicant and reference product sponsor to engage in good faith \par\pard\ql \li2815\ri1143\sb10\sl-230\slmult0 \up0 \expndtw-3\charscalex100 negotiations to determine which (if any) listed patents will be the subject of infringement actions. If, \up0 \expndtw-3\charscalex100 within 15 days of the start of negotiations, no agreement is reached, the procedure for patent \line \up0 \expndtw-4\charscalex100 resolution (see below) must be followed. \par\pard\ql \li2815\sb230\sl-230\slmult0 \up0 \expndtw-4\charscalex100 \ul0\nosupersub\cf11\f12\fs20 Patent Resolutions if No Agreement Reached During Negotiations. \par\pard\ql \li2815\sb230\sl-230\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf6\f7\fs20 351(l)(5).\ul0\nosupersub\cf7\f8\fs20 If no agreement as to which patents will be litigated is reached, the FOB applicant and \par\pard\ql \li2815\sb1\sl-217\slmult0 \up0 \expndtw-3\charscalex100 reference product sponsor must exchange a list of patents they believe should be the subject on an \par\pard\qj \li2815\ri1047\sb21\sl-220\slmult0 \up0 \expndtw-3\charscalex100 infringement suit. The reference product sponsor may not list more than the FOB applicant, unless the \up0 \expndtw-3\charscalex100 FOB applicant lists no patents (in which case the reference product sponsor may list 1 patent). \par\pard\ql \li2815\ri1210\sb230\sl-233\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf6\f7\fs20 351(l)(7).\ul0\nosupersub\cf7\f8\fs20 If the reference product sponsor is licensed a patent after the date that lists are exchanged, \up0 \expndtw-3\charscalex100 the reference product sponsor has 30 days to provide a supplemental list that include that patent, and \up0 \expndtw-3\charscalex100 the FOB applicant then has 30 days to respond with a statement as to why that patents is invalid, \up0 \expndtw-4\charscalex100 unenforceable or not infringed. \par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb80\sl-230\slmult0\fi0\tx2815 \dn2 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Suits for\tab \up0 \expndtw-1\charscalex100 PHS § 351(l)(6).\ul0\nosupersub\cf7\f8\fs20 Within 30 days after a negotiated list is agreed to, or after the exchange of lists\par\pard\li1080\sb0\sl-230\slmult0\fi0\tx2815 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Infringement\tab \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf7\f8\fs20 occurs if negotiations fail, the reference product sponsor must bring an action for infringement for all\par\pard\li2815\sb1\sl-223\slmult0\fi0 \up0 \expndtw-1\charscalex100 patents in the lists. The FOB applicant is required to provide HHS with notice and a copy of the\par\pard\li2815\sb2\sl-229\slmult0\fi0 \up0 \expndtw-1\charscalex100 complaint. HHS must publish notice of the complaint in the Federal Register.\par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb74\sl-230\slmult0\fi0\tx2815 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Preliminary\tab \up0 \expndtw-1\charscalex100 PHS § 351(l)(8).\ul0\nosupersub\cf7\f8\fs20 The FOB applicant is required to notify the reference product sponsor no later than\par\pard\li1080\sb0\sl-230\slmult0\fi0\tx2815 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Injunctions\tab \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf7\f8\fs20 180 days before the first commercial marketing of the FOB.\par\pard\ql \li2815\ri1203\sb0\sl-230\slmult0 \up0 \expndtw-3\charscalex100 After receiving such notice and before the first commercial marketing, the reference product sponsor \up0 \expndtw-3\charscalex100 may petition for a preliminary injunction prohibiting the FOB applicant from marketing the FOB for \up0 \expndtw-3\charscalex100 any patent that is identified in the list provided by the FOB applicant or reference product sponsor \up0 \expndtw-3\charscalex100 under 351(l)(3) (\u8220?listed patents\u8221?) and which is not included (as applicable) in the lists relating to \up0 \expndtw-3\charscalex100 patent litigation (whether negotiated under 351(l)(4) or exchanged under 351(l)(5)). \par\pard\sect\sectd\fs24\paperw12240\paperh15840{\shp
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Pg7}{\bkmkend Pg7}\par\pard\ql \li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb0\sl-253\slmult0 \par\pard\ql\li4876\sb86\sl-253\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf5\f6\fs22 Patient Protection and Affordable Care Act \par\pard\ql \li6386\sb7\sl-253\slmult0 \up0 \expndtw-3\charscalex100 (H.R. 3590) \par\pard\qj \li2815\sb0\sl-240\slmult0 \par\pard\qj\li2815\sb0\sl-240\slmult0 \par\pard\qj\li2815\sb0\sl-240\slmult0 \par\pard\qj\li2815\ri1280\sb18\sl-240\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf7\f8\fs20 Requires \u8220?reasonable cooperation\u8221? between the reference product sponsor and the FOB applicant to \line \up0 \expndtw-3\charscalex100 \u8220?expedite such further discovery\u8221? as is needed to resolve the motion for a preliminary injunction. \par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb78\sl-230\slmult0\fi0\tx2815 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Declaratory\tab \up0 \expndtw-2\charscalex100 PHS § 351(l)(9).\par\pard\li1080\sb1\sl-230\slmult0\fi0\tx2815 \dn2 \expndtw-2\charscalex100 Judgment\tab \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf7\f8\fs20 If the FOB applicant provides appropriate access to confidential information, the reference product\par\pard\li1080\sb0\sl-230\slmult0\fi0\tx2815 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Actions\tab \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf7\f8\fs20 sponsor and FOB applicant are prohibited from bringing action for a declaratory judgment of\par\pard\qj \li2815\ri1126\sb0\sl-240\slmult0 \up0 \expndtw-3\charscalex100 infringement, validity or enforceability of any patent listed by the FOB applicant or reference product \up0 \expndtw-4\charscalex100 sponsor. \par\pard\ql \li2815\sb201\sl-230\slmult0 \up0 \expndtw-4\charscalex100 If the FOB applicant fails to: \par\pard\ql \li2966\ri1055\sb0\sl-240\slmult0\tx3252 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 provide a detailed statement regarding invalidity, non-infringement or unenforceability regarding \line\tab \up0 \expndtw-2\charscalex100 a listed patent; \par\pard\ql \li2966\ri1162\sb0\sl-240\slmult0\tx3252 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 exchange a list of patents for litigation purposes under 351(l)(5) if discussions to negotiate a list \line\tab \up0 \expndtw-2\charscalex100 break down, \par\pard\ql \li2966\sb0\sl-180\slmult0 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 notify HHS after a complaint for patent infringement is served; or \par\pard\ql \li2966\sb11\sl-230\slmult0 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 provide notice within 180 days of the first commercial marketing of the FOB, \par\pard\ql \li2815\sb230\sl-230\slmult0 \up0 \expndtw-1\charscalex100 The reference product sponsor may bring an action for declaratory judgment for any listed patent \par\pard\qj \li2815\ri1443\sb230\sl-230\slmult0 \up0 \expndtw-1\charscalex100 If the FOB applicant fails to provide confidential access to the required information, the reference \line \up0 \expndtw-1\charscalex100 product sponsor may bring a declaratory judgment action for any patent that covers the biological \line \up0 \expndtw-2\charscalex100 product. \par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb77\sl-230\slmult0\fi0\tx2815 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Transition\tab \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf7\f8\fs20 No transitional exclusivity.\par\pard\ql \li1080\sb1\sl-221\slmult0 \up0 \expndtw-4\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Period \par\pard\li1080\sb0\sl-230\slmult0\par\pard\li1080\sb77\sl-230\slmult0\fi0\tx2815 \up0 \expndtw-2\charscalex100 Other\tab \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf7\f8\fs20 Amends\ul0\nosupersub\cf6\f7\fs20 35 U.S.C. 271(e\ul0\nosupersub\cf7\f8\fs20 ):\par\pard\ql \li2947\ri1535\sb4\sl-220\slmult0\tx3187 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 To deem an FOB application seeking approval of a product claimed in a patent or the use of \line\tab \up0 \expndtw-2\charscalex100 which is claimed in a patent an act of infringement. \par\pard\ql \li2947\ri1190\sb12\sl-230\slmult0\tx3187\tx3187 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 To limit the remedies available in any litigation brought after the 30 day window to reasonable \line\tab \up0 \expndtw-1\charscalex100 royalties. This provision has the effect of providing for compulsory licensing if an infringement \line \tab \up0 \expndtw-2\charscalex100 suit is not brought within 30 days. \par\pard\ql \li2947\ri1069\sb0\sl-240\slmult0\tx3187 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 To prohibit the owner of a patent that should have been identified in the patent lists from bringing \line\tab \up0 \expndtw-2\charscalex100 an action for infringement; and \par\pard\ql \li2947\sb1\sl-193\slmult0 \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf8\f9\fs20 \u-3929?\ul0\nosupersub\cf7\f8\fs20 To require the court to issue a permanent injunction prohibiting the FOB applicant from \par\pard\ql \li3187\sb17\sl-230\slmult0 \up0 \expndtw-1\charscalex100 infringing a patent that is found to be infringed by a final court decision until the patent expires. \par\pard\ql \li1080\sb0\sl-230\slmult0 \par\pard\ql\li1080\sb200\sl-230\slmult0 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Payment \par\pard\ql \li4876\sb151\sl-253\slmult0 \up0 \expndtw-3\charscalex100 \ul0\nosupersub\cf5\f6\fs22 Patient Protection and Affordable Care Act \par\pard\ql \li6386\sb7\sl-253\slmult0 \up0 \expndtw-3\charscalex100 (H.R. 3590) \par\pard\li1072\sb0\sl-230\slmult0\par\pard\li1072\sb155\sl-230\slmult0\fi0\tx2808 \up0 \expndtw-2\charscalex100 \ul0\nosupersub\cf6\f7\fs20 Payment\tab \up0 \expndtw-1\charscalex100 \ul0\nosupersub\cf7\f8\fs20 Provides for separate billing codes for Part B biosimilar products; statutorily mandates that\par\pard\qj \li2808\ri1258\sb0\sl-220\slmult0 \up0 \expndtw-1\charscalex100 reimbursement equal the ASP of the biosimilar plus six percent of the ASP of the reference product. \up0 \expndtw-2\charscalex100 (Sec. 3139) \par\pard\sect\sectd\fs24}